Girl dies after receiving cervical cancer vaccine

LONDON (Reuters) - A teenage British girl died after receiving a cervical cancer vaccine made by GlaxoSmithKline, health officials said on Monday.

The British-based drugmaker said the cause of death was as yet unknown, and a health official said on Tuesday that the vaccine, Cervarix, probably did not cause the death.

"I think it is unlikely that will be the case," said Dr Caron Grainger, joint director of public health in the area where the 14-year-old girl died, when asked about the possibility of any connection between the death and Cervarix.

The 14-year-old fell ill after she was given the Cervarix vaccination against the sexually transmitted human papillomavirus (HPV) at her school in Coventry, central England, as part of a national immunisation programme.

She later died in hospital.

"The incident happened shortly after the girl had received her HPV vaccine in the school," Grainger said in a statement Monday.

"No link can be made between the death and the vaccine until all the facts are known and a post mortem takes place. We are conducting an urgent and full investigation into the events surrounding this tragedy."

"We are working with the Department of Health and MHRA (Medicines and Healthcare products Regulatory Agency) to better understand this case, as at this stage the exact cause of this tragic death is unknown," Glaxo medical director Dr Pim Kon said in a statement.

"As a precautionary measure, the batch of vaccine involved has been quarantined until the situation is fully understood."

A small number of other girls at the school reported mild symptoms such as dizziness and nausea but were not admitted to hospital, health officials said.

GlaxoSmithKline, based in Brentford, Middlesex, said more than 1.4 million doses of Cervarix had been given as part of the national immunisation programme.

It said adverse reactions reported so far had related to signs and symptoms of recognised side effects, or were due to the injection and not the vaccine itself.

"I think once we get into the investigation ... we may discover there is another cause of her death," Grainger told the BBC.

"The message for parents at this moment in time and for young girls receiving this vaccine is that you should go ahead with the vaccination," said Grainger, who works for the National Health Service in the central English city of Coventry.

Police are treating the girl's death as "unexplained" and said a post-mortem was taking place on Tuesday.

The teenager, named by a police source as Natalie Morton, fell ill on Monday after being vaccinated at her school under a national immunisation programme against the sexually-transmitted human papilloma virus (HPV).

NO PLANS TO HALT PROGRAM

Britain's Department of Health said there were no plans to halt the programme. "The vaccine has a strong safety record so precautionary measures are focused on the batch," it said in a statement.

Grainger said only about 2,000 people had suffered any adverse reactions to the immunisation programme and that these were mostly minor.

Sudden teenage deaths, in general, are not unknown. "Unfortunately, some young people do die suddenly for a variety of reasons, including cardiac causes. Sometimes they have been entirely well before their death," said Dr David Elliman of London's Great Ormond Street Hospital for Children.

A small number of other girls at the Blue Coat Church of England School reported suffering from dizziness and nausea but were not admitted to hospital, health officials said.

The drug is given in three shots over six months.

The programme to vaccinate girls aged 12 to 13 began in September 2008. Cervical cancer is the 12th most common women's cancer in Britain, killing more than 1,000 women each year.

News of the death came shortly before a possible decision by U.S. health regulators on whether to approve Cervarix for sale in the United States.

Should Cervarix gain U.S. approval it would compete with Merck & Co's Gardasil, which has been on the U.S. market since 2006.

GlaxoSmithKline won support for its cervical cancer vaccine from an advisory panel to Japan's Health Ministry on Tuesday, putting it on track to be the first company to offer such a vaccine in the world's second-biggest drug market.

(reporting by Matthew Jones; editing by Ivan Oransky/Reuters Health)

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